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Docetaxel and Cetuximab in Treating Patients With Metastatic Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00728663
Recruitment Status : Completed
First Posted : August 6, 2008
Last Update Posted : May 14, 2019
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of prostate cancer by blocking blood flow to the tumor. Giving docetaxel together with cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving docetaxel together with cetuximab and to see how well it works in treating patients with metastatic prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: cetuximab Drug: docetaxel Phase 2

Detailed Description:


  • To assess the efficacy and safety of docetaxel and cetuximab in patients with docetaxel-resistant hormone-refractory prostate cancer

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV once weekly and docetaxel IV on day 1 (3-week courses) or on days 1, 8, and 15 (4-week courses). Treatment repeats every 3 weeks for up to 8 courses or every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Docetaxel and Cetuximab in Patients With Docetaxel-resistant Hormone-refractory Prostate Cancer (HRPC). A Multicenter Phase II Trial
Study Start Date : June 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Arm: Cetuximab and Docetaxel

Cetuximab: 400 mg/m2 initial dose on day 1, then 250 mg/m2 weekly starting on day 8 and Docetaxel: 75 mg/m2 day 1 of a 21 day cycle or 35 mg/m2 day 1,8,15 of a 28 day cycle

--- for max. 24 weeks or until progression or unacceptable toxicity ---

Biological: cetuximab

Cetuximab: 400 mg/m2 initial dose on day 1, then 250 mg/m2 weekly starting on day 8

--- for max. 24 weeks or until progression or unacceptable toxicity ---

Other Name: Erbitux

Drug: docetaxel

75 mg/m2 day 1 of a 21 day cycle or 35 mg/m2 day 1,8,15 of a 28 day cycle

--- for max. 24 weeks or until progression or unacceptable toxicity ---

Other Name: Taxotere

Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: at 12 weeks ]
  2. Progression-free survival (PFS) [ Time Frame: at 24 weeks ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: All AEs will be assessed according to NCI CTCAE v3.0. ]
  2. Prostate-specific antigen (PSA) response (30% and 50% PSA response) [ Time Frame: is defined as a decrease in PSA level of at least 50% (compared to baseline PSA) confirmed after 3-4 weeks (according to the PSA working group consensus criteria) ]
  3. Tumor assessment of measurable disease according to RECIST criteria [ Time Frame: after 12 weeks of treatment, or earlier if clinically indicated ]
  4. Tumor assessment of bone lesions [ Time Frame: at 12 weeks ]
  5. Overall survival [ Time Frame: calculated from registration until death. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Metastatic adenocarcinoma of the prostate
  • Must have received one of the following treatment schedules for at least 12 weeks prior to study therapy:

    • Docetaxel 75 mg/m^2 on day 1 of a 21-day course
    • Docetaxel 35 mg/m^2 on days 1, 8, and 15 of a 28-day course
  • Must demonstrate hormone-resistance, defined as tumor progression after orchiectomy or during treatment with hormonal agents (i.e., luteinizing hormone-releasing hormone [LHRH] agonists)
  • Elevated prostate-specific antigen (PSA) > 2 ng/mL and PSA progression after at least 12 weeks treatment with docetaxel/prednisone, within 90 days after discontinuation of docetaxel/prednisone treatment, under continued hormonal treatment (i.e., LHRH agonists or orchiectomy), and meets 1 of the following criteria for PSA progression:

    • PSA increase of ≥ 25% above the nadir
    • PSA increase of ≥ 25% above the baseline if no decrease has been observed

      • The increase is a minimum of 2 ng/mL, and it is confirmed 1 week later
  • No presence or history of CNS metastases


  • WHO performance status 0-2
  • Neutrophils ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT ≤ 2.5 times ULN
  • Creatinine clearance ≥ 30 mL/min
  • Patient compliance and geographic proximity allow proper staging and follow-up
  • Peripheral neuropathy < grade 2
  • No prior malignancy within the past 5 years with the exception of localized nonmelanoma skin cancer or Ta or Tis bladder cancer
  • No known hypersensitivity to trial drugs or any of their components
  • No serious underlying medical condition that, in the judgment of the investigator, would preclude the patient's ability to participate in the trial (e.g., active autoimmune disease, uncontrolled or acute severe infection, or uncontrolled diabetes)
  • No psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, or interfering with oral drug intake compliance


  • See Disease Characteristics
  • More than 2 weeks since prior radiotherapy
  • More than 6 weeks since prior treatment with antiandrogens (i.e., flutamide or bicalutamide)
  • No prior chemotherapy other than docetaxel for metastatic prostate cancer
  • No other concurrent experimental drugs or other anticancer therapy

    • Concurrent bisphosphonates and LHRH agonists allowed provided these medications started at least 2 months prior to study therapy
  • No treatment in a clinical trial within the past 30 days
  • No prior treatment with drugs interacting with epidermal growth factor receptor (i.e., cetuximab, panitumumab, gefitinib, erlotinib hydrochloride, or multi-tyrosine kinase inhibitors)
  • No concurrent drugs that, according to the Swissmedic-approved product information, are contraindicated for use with the trial drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00728663

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Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
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Study Chair: Richard Cathomas, MD Kantonsspital Graubuenden
Principal Investigator: Roger von Moos, MD Kantonsspital Graubuenden
Principal Investigator: Silke Gillessen, MD Cantonal Hospital of St. Gallen
Publications of Results:
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Responsible Party: Swiss Group for Clinical Cancer Research Identifier: NCT00728663    
Other Study ID Numbers: SAKK 08/07
First Posted: August 6, 2008    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: April 2014
Keywords provided by Swiss Group for Clinical Cancer Research:
adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological